WEBINARS

 

Compliance Training Webinars for Regulated Industries

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How to Audit the Difficult Areas of a Quality Management System

webinar-speaker   Larry Whittington

webinar-time   60 Min

Product Id: 700334

This webinar will provide guidance on how to audit the more difficult areas of a quality management system The applicable ISO 9001:2000 requirements will be examined for each of these difficult areas and then suggestions made on how to more effectively audit them

Recording Available

 

Parallel Scientific Advice: How effective is the system established between the EMEA and the FDA

webinar-speaker   Elisabethann Wright

webinar-time   60 Min

Product Id: 700262

This Pharmaceutical training examines the system its benefits and its drawbacks and how effective is the system established between the EMEA and the FDA. The authorization of medical products by the FDA is not recognized in the EU. Neither is authorization by the EMEA Recognized by the FDA.

Recording Available

* Per Attendee $249

 

The Revision of the Medical Devices Directive 93/42/EEC, Background, Proposal and What It Means

webinar-speaker   Trevor Lewis

webinar-time   60 Min

Product Id: 700148

Key insights to the background of the revision for medical device manufacturers with products in Europe. The Medical Devices Directive 93/42/EEC (MDD) is the key European Directive for regulatory compliance and placing of a CE mark on a medical device.

Recording Available

* Per Attendee $249

 

ISO 27001: The risk assessment, control selection and risk treatment plan

webinar-speaker   Alan Calder

webinar-time   60 Min

Product Id: 700300

In this Quality compliance training topics will be related to the risk assessment, control selection and risk treatment plan for developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005. This is a part of a series of webinars that support those considering or developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005.

Recording Available

 

Internal Audit and Risk Mitigation - Effective and practical use of the COSO and COBiT methodologies

webinar-speaker   Vic Datta

webinar-time   60 Min

Product Id: 700296

This Internal audit training is to align the audit risk assessment, audit ecosystem, audit plan, and audit engagements with the larger organization’s strategy, vision, and values.

Recording Available

 

How to Manage an FDA Inspection

webinar-speaker   Susan C Reilly

webinar-time   60 min

Product Id: 700298

This FDA Inspection training is designed to provide the tools and practices necessary to effectively prepare for and manage a successful FDA inspection.

Recording Available

 

Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971

webinar-speaker   Phil Smart

webinar-time   60 Min

Product Id: 700272

This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.

Recording Available

 

Best Practices in Monitoring and Measurement Tools & Techniques to ensure that Your Organization's Processes are performing Up to Expectations

webinar-speaker   Michael A Mathe

webinar-time   60 Min

Product Id: 700268

This Quality compliance training will present and identify ways that your (ISO 9001 8.2.3) process monitoring and measurement tools can Lead your organization to fast and efficient corrections when problems occur.

Recording Available

* Per Attendee $249

 

Establishing Effective Business Strategies for Managing Outsourced Services

webinar-speaker   Richard Barrett

webinar-time   60 Min

Product Id: 700275

This Pharmaceutical training starts with the drivers for outsourcing and investigates the importance of measures of success and how they apply in implementing strategy.

Recording Available

 

Technology Transfer of a Pharmaceutical Manufacturing Process

webinar-speaker   Rodney E Thompson

webinar-time   60 Min

Product Id: 700247

This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.

Recording Available

 

Auditing a Process-based System

webinar-speaker   Dr. Sandford Liebesman

webinar-time   60 Min

Product Id: 700260

This Internal Audit training will provide valuable assistance to organizations desiring to comply with ISO 9001:2000 and will provide the internal audit functions with methodology and tools to better perform internal audits.

Recording Available

 

Outsourcing analytical and pharmaceutical development

webinar-speaker   Michael Gamlen

webinar-time   60 Min

Product Id: 700231

This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.

Recording Available

 

Recording Available

* Per Attendee $599

 

Recording Available

* Per Attendee $499

 

Implications of the US PATRIOT Act for international financial services agencies

webinar-speaker   Kenneth Barden

webinar-time   60 Min

Product Id: 700248

In this Financial services training will examine the provisions of the PATRIOT Act that affect international financial institutions, along with recent regulations implementing those provisions.

Recording Available

 

Quality Management for FDA QSR and ISO13485 Compliance: Pack of Two Courses

webinar-speaker   Susan C Reilly,William G Mclain

webinar-time  

Product Id: 700289

Best practices in Quality Management System and management controls needed to meet US FDA and ISO 13485 requirements This pack of two training courses provides 2 hours of training on basic requirements and best practices of quality management system for non-Regulatory and Quality Assurance experts in the medical devices industry as well as principles and practices needed to effectively develop and implement the Management Controls necessary to ensure an effective Quality Management System (QMS) and to comply with the requirements of the FDA QS Regulation

Recording Available

* Per Attendee $399

 

ISO 27001: Relationship to other standards - ISO 17799, ISO 20000, CobiT, and the integrated management system

webinar-speaker   Alan Calder

webinar-time   60 Min

Product Id: 700244

In this Quality compliance training comprehensive guidance on ISO/IEC 27001:2005 that will aid and assist practitioners and managers the world over.

Recording Available

 

What Every Firm Should Know About Business Continuity Compliance

webinar-speaker   Henry Theberge

webinar-time   60 Min

Product Id: 700251

This Corporate governance training will provide a basic understanding of business continuity, discuss why business continuity is important, for compliance with rule 466 and others, clarify what to look for during audits.

Recording Available

* Per Attendee $249

 

Validation of Computerized Analytical Systems

webinar-speaker   Dr. Ludwig Huber

webinar-time   60 Min

Product Id: 700212

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

Recording Available

* Per Attendee $249

 

Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700245

This Medical device training will explain the regulatory requirements including cleaning and sterilization methods & validations.

Recording Available

* Per Attendee $249

 

 

 

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